Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study

This study has been completed.
Sponsor:
Information provided by:
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00771186
First received: October 10, 2008
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

The goal of this study is to further study the role of LEMG in accurately predicting the recovery of vocal function as well to study the timing of a change of LEMG activity prior to such return of function. We aim to do this by collaborating with several active pediatric otolaryngological practices throughout the country who in turn have agreed to evaluate infants and children with vocal fold immobility who fit a standardized inclusion and exclusion criteria by means of a standardized LEMG protocol over a one year period of time. Our particular goal is to collect and then review information over a one year period of time on all children evaluated for vocal fold immobility by means of LEMG.


Condition
Vocal Fold Immobility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • return of vocal fold function [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
children with vocal fold immobility

  Hide Detailed Description

Detailed Description:

Study design:

Primary central hypothesis:

Operative LEMG performed in a serial fashion can predict return of RLN function in children after iatrogenic injury.

Secondary hypothesis:

Operative LEMG performed in a serial fashion will allow some projection as to the timing of RLN recovery

Inclusion criteria:

  1. Children age 0-18 with vocal fold immobility documented by laryngeal fiberoptic evaluation
  2. Children who have had a recent, identifiable cardiac surgical etiology for RLN injury and subsequent VFI
  3. Children whose parents sign informed consent and who themselves sign assent if they are old enough to do so.

Exclusion criteria

  1. Children whose families do not give informed consent or who themselves do not give informed assent ( if the children are old enough to understand)
  2. Children with congenital VFI where the etiology is not clearly identified

Data to be recorded:

  1. Age of patient
  2. Gender
  3. Age of initial fiberoptic evaluation and of initial diagnosis
  4. Diagnosis
  5. Serial Laryngeal Recordings
  6. Fiberoptic Evaluations

LEMG Recording

While in a light plane of anesthesia, the following recordings will be routinely performed:

  1. 10 seconds of both right and left vocal fold LEMG simultaneously recorded with a gain of 50 V
  2. 10 seconds of both right and left vocal fold LEMG simultaneously recorded with a gain of 200 V
  3. 10 seconds of right vocal fold LEMG recorded with a gain of 50 V
  4. 10 seconds of right vocal fold LEMG recorded with a gain of 200 V
  5. 10 seconds of left vocal fold LEMG recorded with a gain of 50 V
  6. 10 seconds of left vocal fold LEMG recorded with a gain of 200 V

Total recording time: 60 seconds

Timing of LEMG and Awake Fiberoptic Laryngoscopy

Following current standard clinical evaluation we are performing at MEEI, we propose to perform awake fiberoptic laryngoscopy and operative LEMG at the following time points: initially (within 3 weeks of injury if possible), at the 3 month post-injury mark, and at the 9- month post injury mark ( 3 recordings in total; we will perform a final fiberoptic laryngoscopy in the office at the one year time interval). The time points were chosen as each recording necessitates an operative procedure with general anesthesia so we wanted to limit the over number of general anesthetics. We recognize that the risk of limiting the number of operative LEMG recordings is that we lose some data-points to chart recovery of RLN function, but we felt that the risks of multiple general anesthetics were sufficient enough to warrant limiting the number of recordings as much as possible.

Data Collection and Database protection

All Data collected will be entered into a password protected database.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children with vocal fold immobility

Criteria

Inclusion Criteria:

  1. Children age 0-18 with vocal fold immobility documented by laryngeal fiberoptic evaluation
  2. Children who have had a recent, identifiable cardiac surgical etiology for RLN injury and subsequent VFI
  3. Children whose parents sign informed consent and who themselves sign assent if they are old enough to do so

Exclusion Criteria:

  1. Children whose families do not give informed consent or who themselves do not give informed assent ( if the children are old enough to understand)
  2. Children with congenital VFI where the etiology is not clearly identified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771186

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Christopher J Hartnick, MD Massachusetts Eye and Ear Infirmary
  More Information

No publications provided by Massachusetts Eye and Ear Infirmary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Hartnick MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00771186     History of Changes
Other Study ID Numbers: 07-12-078x
Study First Received: October 10, 2008
Last Updated: June 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
pediatric
Laryngeal EMG

ClinicalTrials.gov processed this record on September 22, 2014